510(k) Report

Devices descending from K210595

3 later devices reach SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+1K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+1K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—